Case Study // Surgical Technologies

Collaborative Transfer of Surgical Device Meets Aggressive Time Frame

CUSTOMER SITUATION

A leading, multinational medical technology company needed to transfer manufacturing of a medical device to free up cleanroom manufacturing space for a new product. The customer was facing an aggressive 12-month time frame for the transfer to avoid interrupting product supply.

The technology transfer involved a complex, single-use, molded electromechanical hand piece used in a urology procedure. The programmable device comprised more than 40 components, including temperature sensors, nitinol needles, and an irrigation port.

The customer chose to work with Vention because it offered:

  • Experience manufacturing similar complex medical devices
  • The capability to manage a large-scale technology transfer
  • A manufacturing facility near the customer’s site

VENTION SOLUTION

Vention’s dedicated, cross-functional team worked in tandem with the customer’s transfer team to transition every process, from procuring materials to assembly, kitting, and sterilization. Vention also had the flexibility to draw resources from other sites when the team needed additional expertise.

The Vention team:

  • Built a 3,500 square-foot, Class 8 cleanroom
  • Took over supply chain management (>40 suppliers)
  • Performed more than 70 successful validations

The process of assembling more than 40 components into the device included 13 different manufacturing stations, including joint soldering performed under a microscope.

The transfer provided the opportunity to transition from batch manufacturing to one-piece flow, which added value by reducing manufacturing space and realizing significant improvements in throughput, cycle time, work in process (WIP), and yield.

OUTCOME

Despite the aggressive timeline, Vention was able to smoothly transfer this complex device on time and on budget, while meeting all quality requirements.

In addition, the transition to one-piece flow realized efficiencies, including more than:

  • 30% throughput improvement
  • 30% cycle time reduction
  • 50% WIP reduction
  • 7% yield improvement
  • 50% space reduction

In the year after the transfer, Vention worked with the customer to optimize supply chain, reducing costs and improving supplier quality.

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